Clearance Summary
SOF-SUCTION FLUID EVACUATION SYSTEM received FDA 510(k) clearance under submission number K990749, sponsored by X-Tech Medical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-04-02.
- Submission: K990749
- Applicant / Sponsor: X-Tech Medical, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 1999-04-02
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.